]>
IRCT20150119020715N8 IRCT 2018-07-22 Arak University of Medical Sciences The effect of intravenous Vitamin B6 administration in Prevention of nausea and vomiting due to chemotherapy in pediatrics. The effect of intravenous Vitamin B6 administration in Prevention of chemotherapy induced nausea and vomiting in children with malignancy. 2017-04-21 anticipated 100 Complete https://irct.ir/trial/30793 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Blinding description: Clinical care will be blind of the type of medication. Researchers are also blind of the grouping. Data analyzer is also blind of the grouping. 3 nausea and vomiting. Intervention 1: Intervention group: In a cycle of chemotherapy for the patient, in addition to the use of Granisetron (3 mg / 3 ml), injected into the sample for a half-hour before the chemotherapy was given intravenously vitamin B6 (in the age group of 2-5 years 100 mg - 5-10 years 200 mg - over 10 years 300 mg) 6 hours before chemotherapy is given to an individual. Intervention 2: Control group: In the next cycle of chemotherapy, the same patient as the same previous chemotherapy drug, in addition to the Granisetron, was used as placebo in the same dose of distilled water, and the distilled water was injected intravenously 6 hours before chemotherapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants information will remain confidential
public Dr Aziz Eghbali
Amir Kabir Hospital, Alamalhoda street, Arak
Arak Iran (Islamic Republic of) 3819691187 +98 86 3313 4715 aziz_eghbali@yahoo.com Arak University of Medical Sciences scientific Dr Aziz Eghbali
Amir Kabir Hospital, Alamalhoda street, Arak
Arak Iran (Islamic Republic of) 3819691187 +98 86 3313 4715 aziz_eghbali@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) desire to participate in the study Children with malignancy who need to chemotherapy 2 to 15 years of age 2 years 15 years Both Unwilling to participate in the study patients with Immune deficiency patients with cardiovascular disease patients with AIDS patients with renal failure patients with diabetes R11.2 Nausea with vomiting, unspecified Treatment - Drugs Placebo Intervention group: In a cycle of chemotherapy for the patient, in addition to the use of Granisetron (3 mg / 3 ml), injected into the sample for a half-hour before the chemotherapy was given intravenously vitamin B6 (in the age group of 2-5 years 100 mg - 5-10 years 200 mg - over 10 years 300 mg) 6 hours before chemotherapy is given to an individual. Control group: In the next cycle of chemotherapy, the same patient as the same previous chemotherapy drug, in addition to the Granisetron, was used as placebo in the same dose of distilled water, and the distilled water was injected intravenously 6 hours before chemotherapy. Nausea and vomiting. Timepoint: The frequency of nausea and vomiting is recorded within 24 hours. Method of measurement: Recorded in checklist. Arak University of Medical Sciences Approved 2017-03-06 Ethics Committee of Arak University of Medical Sciences Arak University of Medical Sciences, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)